Actively Recruiting

Phase Not Applicable
Age: 1Day - 3Weeks
All Genders
NCT05675397

Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants

Led by National and Kapodistrian University of Athens · Updated on 2023-01-09

200

Participants Needed

2

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.

CONDITIONS

Official Title

Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants

Who Can Participate

Age: 1Day - 3Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Very low birth weight (VLBW) infants with birth weight less than 1500 grams
  • Born to mothers who agree to provide donor milk for the first three weeks of life if their own milk is insufficient
Not Eligible

You will not qualify if you...

  • Presence of congenital anomalies
  • Presence of chromosomal disorders
  • Presence of metabolic diseases
  • Feeding with formula at any point during the first three weeks of life

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital

Athens, Greece, 11521

Actively Recruiting

2

First Department of Pediatrics, National and Kapodistrian University of Athens

Athens, Greece, 11527

Not Yet Recruiting

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Research Team

T

Tania Siahanidou, MD, PhD

CONTACT

G

Giannoula Gialeli, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants | DecenTrialz